ce CONTINUING EDUCATION
versus placebo and showed a statistically significant decrease in the incidence of medically attended LRTI caused by RT-PCR-confirmed RSV, charac- terized predominantly as bronchiolitis or pneumonia through 150 days after dosing. Trial 05 studied nir- sevimab-alip versus palivisumab (a monoclonal antibody directed against RSV in premature and at-risk infants) and showed only a slight decrease in the incidence of medically attended LRTI caused by RSV. Administration: Nirsevimab-alip is administered as an IM injection based on body weight (Table 1); 50 mg is administered if the infant is less than 5 kg; 100 mg is administered if the infant is greater than or equal to 5 kg; up to 200 mg is given as two sep- arate injections (2 X 100mg) for children up to 24 months of age.
Additional Notes: Like other vaccines, there is a risk of syncope and anaphylaxis. These reactions typically occur within a few minutes after administra- tion. Advise the patient to stay in the pharmacy area for 30 minutes after administration to observe for any potential reaction. Also, it is federal law to pro- vide the Vaccine Information Statement (VIS) with each dose of a vaccine, which highlights important information about the benefits and risks. Beyfortus (nirsevimab-alip) Indication and Mechanism of Action: Nirsevimab- alip is a vaccine approved for the prevention of RSV and lower respiratory tract infections (LRTI) in neo- nates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable during their second season. Nirsevimab-alip is an recombinant human monoclo- nal antibody that provides passive immunity against RSV activity by targeting the prefusion conformation of the RSV F protein. It is long-acting as a single dose from hospitalization (birth) through the 150 days of the RSV season. Two out of 3 babies get RSV by age 1 and are sixteen times more likely to be hospitalized due to complications associated with RSV as compared to the flu. The FDA’s approval is based on the data from three clinical trials: Trial 03, 04 and 05. Trials 03 and 04 studied nirsevimab-alip
BODY WEIGHT AT TIME OF DOSING/ AGE
RECOMMENDED DOSAGE
<5 kg ≥ 5 kg
50 mg via IM 100 mg via IM
Up to 24 months
200 mg (2 x 100 mg via IM)
For neonates and infants born during or entering the RSV season, administer nirsevimab-alip start- ing from birth. For infants born outside the RSV season, administer nirsevimab-alip once prior to the start of the RSV season considering the dura- tion of protection provided by nirsevimab-alip. It can be co-administered with other childhood vaccines in a separate syringe and in different injection sites. It is recommended by both the American Academy of Pediatrics (AAP) and the ACIP. Safety: It should be used with caution in patients with clinically significant bleeding disorders. For children undergoing cardiac surgery with cardiopul- monary bypass, an additional dose is recommended as soon as the child is stable after surgery. Nirsevimab-alip is generally well tolerated. The most common side effects are rash and injection-site reactions (swelling, pain, and hardness) within 7 days post-dose.
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